MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach.
ITAC
1 other identifier
observational
40
1 country
1
Brief Summary
This pilot prospective study will investigate the role of microbiota and known enteropathogens in Acute Severe Ulcerative Colitis (ASUC). Investigators will compare a group of patients hospitalized for an ASUC with patients experiencing a Non-Severe Ulcerative Colitis (NSUC) flare by investigating microbiome, metabolome and transcriptome and integrating this data through a multi-omic framework. This systems biology approach aims at enhance our understanding of this severe event, define diagnosis and prognosis biomarkers to improve medical therapy and avoid colectomy and/or death.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedStudy Start
First participant enrolled
May 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMay 26, 2020
February 1, 2020
9 months
February 14, 2020
May 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analysis of the faecal microbiota in each group.
Sequencing of the V4 region of the 16S rRNA gene at inclusion on the colonic biopsies taken during routine sigmoidoscopy.
Inclusion Visit
Secondary Outcomes (2)
Diagnosis of Clostridium difficile infections
Inclusion Visit
Diagnosis of Cytomegalovirus (CMV) infections
baseline
Study Arms (2)
Acute Severe Ulcerative Colitis group
Non-severe Ulcerative Colitis group
Interventions
At inclusion, at day 5, day 42 and at 3 months, one 2 ml EDTA blood tube will be collected for metabolomics. Polar metabolites, lipids, free fatty acids and bile acids will be identified and quantitated using ultra high-performance liquid chromatography/tandem accurate mass spectrometry method. At inclusion, one 2 ml EDTA tube will be stored as a DNA collection.
One stool sample will be taken at baseline, day 5, day 42 and at 3 months and frozen at -80°C and divided in 2 aliquots. One stool aliquot will be used for metabolomics. Polar metabolites, lipids, free fatty acids and bile acids will be identified and quantitated using ultra high-performance liquid chromatography/tandem accurate mass spectrometry method. The other one will be used for microbiota analysis. Samples will be sent to the McGill University (Prof. SALEH's lab) for extraction and then, Génome Québec Innovation Centre (McGill University, Montréal, Canada) for sequencing of the V4 region of the 16S rRNA gene on Illumina MiSeq in paired-end mode.
During routine flexible sigmoidoscopy, 6 biopsies will be collected with a 5 mm biopsy forceps at baseline and at 3 months. Biopsies will be placed into a sterile vial containing RNAlater (Qiagen, Hilden, Germany) and stored at -80°C. Two biopsies will be used for mucosal microbiome analysis in the same way as the stool sample. Four biopsies will be used for RNAseq. Samples will be shipped to Prof. SALEH's lab in Montréal for nucleic acid extraction. The McGill University and Génome Québec Innovation Centre (McGill University, Montréal, Canada) will provide library preparation and next generation sequencing. The average number of uniquely mapped reads per sequencing run will be 30 million reads per sample.
Eligibility Criteria
Patients diagnosed with Ulcerative Colitis according to usual criteria.
You may qualify if:
- All patients:
- Adult patients diagnosed with Ulcerative Colitis according to usual criteria.
- ASUC group:
- Adult patients hospitalized an ASUC defined according to Truelove criteria, i.e. ≥6 bloody daily stools with one or more of the following criteria: temperature \>37.8°C, pulse \>90 beats/min, haemoglobin \<10.5g/dl or C Reactive-Protein \>45mg/l.
- Non severe acute UC patients (NSUC) group:
- Adult patients with disease activity symptoms, corresponding to a partial Mayo score of 4 or more with a rectal bleeding subscore of at least 1, without Truelove severity criteria.
You may not qualify if:
- Patients with perianal lesions, ileal lesions or endoscopic aspect of the colonic lesions related to a Crohn's disease acute severe colitis.
- Patients under 18 years old.
- Patients under legal protection or unable to express their consent.
- Patients not affiliated to a health insurance system.
- Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076, France
Biospecimen
whole blood sample, stool and colonic biopsies
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2020
First Posted
February 17, 2020
Study Start
May 14, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2022
Last Updated
May 26, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share